USP Development Scientist I
MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.
Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.
Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.
Purpose of Job
The purpose of the job is to support the USP Process Development department in the design, understanding and tech transfer of AAV Manufacturing processes, including but not limited to suspension cell culture optimization, transient transfection strategies, AAV production scale-up and intensification.
- Support lab experiments within the USP Development team, aiming to scale-up, intensify and improve the robustness of in-house AAV manufacturing operations at MeiraGTx.
- Collaborate in the optimization of AAV manufacturing unit operations, including but not limited to seed train, stirred tank bioreactor production, fed batch/perfusion strategies, depth filtration.
- Operate bioreactors at 250mL to 50L scale to support USP optimization and material generation for DSP development and analytical characterization activities.
- Participate in the continuous collection of process data, to improve process understanding, ensure process reproducibility and robustness.
- Drive innovation and challenge conventional assumptions to ensure MeiraGTx stays on the leading edge of manufacturing science and technology, such as the use new process technologies, automation and high throughput development tools, statistical and mechanistic process modelling and DoE techniques.
- Use process analytical tools, multivariate data analytics software (SAS JMP) and programming tools (Excel VBA, Python) to generate comprehensive and structured datasets and identify optimization opportunities.
- Present experimental data to various departments at MeiraGTx to support process changes and tech transfer activities.
- Maintain cells routinely in shaker flasks.
- Perform analytical tasks such as qPCR, ddPCR, ELISA, Gyrolab, Picogreen (manually and on automated liquid handling platforms) to support data generation.
- Participate in routine maintenance of laboratory equipment.
- Draft SOPs and Work instructions for the unit operations that are being developed.
Key Performance Indicators
- Design, schedule and write experimental plans according to changes in business priorities.
- Timely and accurate completion of experiments according to study protocols.
- Present data to key stakeholders in a comprehensive and timely manner to support go/no-go decision points.
- Write Process Development reports to support tech transfer/clinical/commercial filing documentation.
Key Technical Competencies
- Knowledge of Engineering principles for scale-up of upstream bioprocess operations.
- Familiarity with GMP and QbD considerations in a large scale manufacturing environment.
- Understanding and experience with statistical and modelling software and tools, such as DoE and statistical tests (ANOVA, t-test).
- Experience with running DNA and protein quantification assays such as qPCR, ELISA, Picogreen.
- Experience with programming languages such as VBA, Python, SQL or Matlab is desirable.
Key Job Competencies
- Analytical mindset- Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
- Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
- Change Management – Develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates results.
- Motivation – sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence;
- Planning/Organizing – prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules their tasks; develops realistic action plans.
- Professionalism – approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.
- Innovation – displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
- Oral Communication – speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings.
- Written Communication – writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
- PhD, EngD or MSc degree in a relevant Bioprocess/Biochemical/Chemical Engineering or Biochemistry field and < 1 year biotech industry experience in process development;
- BSc degree in Bioprocess/Biochemical/Chemical Engineering or Biochemistry or equivalent and 1-2 years of biotech industry experience in process development